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RECRUITING
NCT07249775

A First-in-Human Study of FID-022 in Solid Tumor Patients

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

Summary

This observational study aims to (1) validate a multimodal artificial intelligence (AI) model for early detection of cancer-associated cachexia in pancreatic cancer patients and (2) assess the feasibility and acceptability of diet and exercise interventions for cachexia management. The study will use retrospective data from the Florida Pancreas Collaborative and prospective data from newly diagnosed patients at Moffitt Cancer Center.

Official title: AI-Driven Early Detection of Cachexia in Pancreatic Cancer and Feasibility of Diet and Exercise Interventions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-10-08

Completion Date

2026-10

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

OTHER

Baseline Lifestyle and Symptom Assessment

Dietary questionnaire (VioScreen), symptom and QoL surveys (ESAS-r, FAACT, PROMIS PF, PG-SGA), physical activity survey (Modified GLTEQ), functional fitness tests, DEXA scans, blood draws.

OTHER

Extended Lifestyle Monitoring

Wearable monitoring (Fitbit) and diet/physical activity preference survey at 9 months.

OTHER

Feasibility Survey

One-time structured survey assessing integration of diet and exercise interventions into clinical workflow.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States